Mexico COFEPRIS Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
Regulatory Framework
Regulatory Authority: COFEPRIS (Comision Federal para la Proteccion contra Riesgos Sanitarios)
Key Legislation:
- Ley General de Salud (General Health Law)
- NOM-241-SSA1-2025: Good Manufacturing Practices for Medical Devices (replaced NOM-241-SSA1-2021, effective April 2025)
- NOM-137-SSA1-2008: Labeling of Medical Devices
Classification: Risk-based, 3 classes:
- Class I (low risk) | Class II (medium risk) | Class III (high risk)
Registration Pathway:
- Standard route: Full technical dossier submission with GMP certification
- Abbreviated Regulatory Pathway (Equivalency Route): For devices approved by reference authorities (FDA, EU, MDSAP members) -- 30 business day target review
- GMP certification: COFEPRIS BPF certificate, or ISO 13485 / MDSAP certificate accepted as equivalent
Key Requirements:
- Sanitary Registration (Registro Sanitario) required before commercialization
- Local authorized representative required for foreign manufacturers
- NOM-241-SSA1-2025 GMP compliance (MDSAP recognized as equivalent)
- Spanish-language labeling and IFU required (per NOM-137)
- Certificate of Free Sale (CFS) from country of origin
Current Key Guidance:
- NOM-241-SSA1-2025 (DOF Publication)
- COFEPRIS Medical Devices Portal
- Abbreviated Pathway (Via Regulatoria Abreviada, DOF 2025)
Latest Updates
COFEPRIS Strengthens Coordination for Health Emergencies During 2026 Rainy and Hurricane Season
2026-09-12 | Mexico COFEPRIS | Safety Communication | !! MEDIUM
This COFEPRIS notice announces strengthened interinstitutional coordination to respond to health emergencies during Mexico’s 2026 rainy and hurricane season. It does not identify a specific medical device, manufacturer, or lot; rather, it addresses system-wide preparedness for ensuring the safety, quality, and availability of medical supplies and devices in affected areas. Healthcare professionals and establishments should review emergency response plans, verify storage and integrity of devices and supplies, and follow COFEPRIS communication channels for incident reporting and guidance.
Tags: cofepris, emergency_preparedness, medical_device_safety, hurricane_season, mexico
COFEPRIS publica Visor de Registros Sanitarios de Dispositivos Médicos
2026-08-29 | Mexico COFEPRIS | Safety Communication | !! MEDIUM
COFEPRIS Alert: COFEPRIS publica Visor de Registros Sanitarios de Dispositivos Médicos